België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz gmbh - rivaroxaban 15 mg (rode tablet 15 mg); rivaroxaban 20 mg (bruin-rode tablet 20 mg) - filmomhulde tablet - 15 mg + 20 mg - rivaroxaban 15 mg; rivaroxaban 20 mg - rivaroxaban

Europese Unie - Nederlands - EMA (European Medicines Agency)

mylan ireland limited - rivaroxaban - venous thromboembolism; pulmonary embolism; acute coronary syndrome; stroke; coronary artery disease; peripheral arterial disease; atrial fibrillation - antitrombotische middelen - rivaroxaban mylan co-administered with acetylsalicylic acid (asa) alone or with asa plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers.  rivaroxaban mylan co-administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events.  ------prevention of venous thromboembolism (vte) in adult patients undergoing elective hip or knee replacement surgery.  treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe), and prevention of recurrent dvt and pe in adults. -------adults prevention of stroke and systemic embolism in adult   patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. paediatric population treatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

aurobindo pharma b.v. baarnsche dijk 1 3741 ln baarn - rivaroxaban 20 mg/stuk ; rivaroxaban 15 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460) ; croscarmellose natrium (e 468) ; hypromellose, type 2910 (3 - 15 mpa.s) (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 3350 ; magnesiumstearaat (e 470b) ; natriumlaurilsulfaat (e 487) ; polyvinylalcohol, gedeeltelijk gehydrolyseerd (e1203) ; talk (e 553 b) ; titaandioxide (e 171) - rivaroxaban

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

krka d.d. novo mesto d.d. - rivaroxaban 15 mg - filmomhulde tablet - 15 mg - rivaroxaban 15 mg - rivaroxaban

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

krka d.d. novo mesto d.d. - rivaroxaban 20 mg - filmomhulde tablet - 20 mg - rivaroxaban 20 mg - rivaroxaban

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

rivaroxaban 20 mg/stuk ; rivaroxaban 15 mg/stuk - filmomhulde tablet - cellulose, microkristallijn (e 460) ; crospovidon (e 1202) ; hypromellose (e 464) ; ijzeroxide rood (e 172) ; lactose 1-water ; macrogol 4000 ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; natriumlaurilsulfaat (e 487) ; povidon k 30 (e 1201) ; titaandioxide (e 171)

Nederland - Nederlands - CBG-MEB (College ter Beoordeling van Geneesmiddelen)

rivaroxaban 20 mg/stuk ; rivaroxaban 15 mg/stuk - capsule, hard - erythrosine (e 127) ; gelatine (e 441) ; ijzeroxide geel (e 172) ; ijzeroxide rood (e 172) ; ijzeroxide zwart (e 172) ; lactose 1-water ; magnesiumstearaat (e 470b) ; maÏszetmeel, gepregelatineerd ; natriumlaurilsulfaat (e 487) ; natriumzetmeelglycolaat ; siliciumdioxide (e 551) ; titaandioxide (e 171)

Europese Unie - Nederlands - EMA (European Medicines Agency)

accord healthcare s.l.u. - rivaroxaban - acute coronary syndrome; coronary artery disease; peripheral arterial disease; venous thromboembolism; stroke; atrial fibrillation; pulmonary embolism - antitrombotische middelen - preventie van veneuze trombo-embolie (vte) bij volwassen patiënten die een electieve heup- of knievervangende operatie ondergaan. behandeling van diepe veneuze trombose (dvt) en longembolie (pe) en preventie van recidiverende dvt en pe bij volwassenen. (see section 4. 4 for haemodynamically unstable pe patients. behandeling van diepe veneuze trombose (dvt) en longembolie (pe) en preventie van recidiverende dvt en pe bij volwassenen. (see section 4. 4 voor haemodynamically instabiel pe-patiënten). adultsprevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. behandeling van diepe veneuze trombose (dvt) en longembolie (pe) en preventie van recidiverende dvt en pe bij volwassenen. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. rivaroxaban accord, co administered with acetylsalicylic acid (asa) alone or with asa plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (acs) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 en 5. rivaroxaban accord, co administered with acetylsalicylic acid (asa), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (cad) or symptomatic peripheral artery disease (pad) at high risk of ischaemic events. adultsprevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. behandeling van diepe veneuze trombose (dvt) en longembolie (pe) en preventie van recidiverende dvt en pe bij volwassenen. (see section 4. 4 for haemodynamically unstable pe patients. )paediatric populationtreatment of venous thromboembolism (vte) and prevention of vte recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz gmbh - rivaroxaban 15 mg - filmomhulde tablet - 15 mg - rivaroxaban 15 mg - rivaroxaban

België - Nederlands - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

sandoz gmbh - rivaroxaban 20 mg - filmomhulde tablet - 20 mg - rivaroxaban 20 mg - rivaroxaban